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Elastomeric Products Professional Guide 8 1 The Infusor Promoting Patient Mobility ™ The Baxter Infusor, Intermate and Folfusor devices utilise Elastomeric technology to provide reliable infusion treatment while promoting patient recovery. They also improve patients quality of life by allowing ambulatory treatment without the inconvenience of programming, power sources and erroneous alarms. The major indications are: Infusional chemotherapy Pain management Antibiotic therapy (Cystic Fibrosis, Osteomyelitis, HIV) Chelation (thalassemia) The administration routes that can be used are: IV Intra-arterial Subcutaneous Epidural Pain Management (incl.wound infusion and nerve blocks) The Infusor or Intermate – with their lightweight disposable design and silent operation – allow patients to continue therapy in any setting. The Infusor and Intermate offers patients a medication delivery system that is comfortable, portable and adaptable to both their therapy and lifestyle needs. 2 2 The Infusor and Intermate may be stored at room temperature or in the refrigerator. Storage conditions are determined by drug stability. To store the Infusor or Intermate at ROOM TEMPERATURE choose a cool, dry place that is: Clean Away from direct sunlight Away from heat sources such as an oven or heater How should the devices be stored? Important points to note: Infusor to extremes of temperature or direct sunlight. Patients should try not to get their catheter wet in the shower. Patients should keep the Infusor and the Intermate out of the reach of children. The Infusor and Intermate are single use only. The Infusor and Intermate Where the Infusor or the Intermate damaged To store the Infusor or Intermate in THE REFRIGERATOR: Make sure the Infusor or the Intermate are not touching each other so air can circulate around them. Keep the Infusor or the Intermate in a separate compartment of the refrigerator. device. Epidural administration of drugs other than those indicated for epidural use could result in serious injury to the patient. The Infusor LV device is not designed for rapid infusion of medications. If using an INTERMATE device, allow the device to warm up to room temperature before use (approx 4-6 hours) 3 3 Using the ™ Infusor or ™ Intermate Getting ready to use the devices 1. The Infusor should be removed from the refrigerator directly before use unless otherwise instructed. The Intermate should be removed from the refrigerator 4-6 hours before use unless otherwise instructed. 2. with soap and water and dry thoroughly 3. need on the clean surface. Lay out these instructions where you can follow them, without having to touch them, as you connect your Infusor or Intermate. 4. Check the name of the medication on the label. 5. Check the expiration date on the label. 6. Check that your name is correct on the label. 7. Wash your hands with hot water and soap. Dry thoroughly. 4 Connecting the Infusor or Intermate to the catheter 1 2 3 4 4 5 Remove the luer cap from the end of the Infusor or intermate tubing. Check to make sure that liquid has moved to the end of the tubing. 5 Replace the Luer Cap. 6 Flush the IV line as instructed. Make sure that the catheter is clamped, then remove and discard the end cap. While still holding the IV line, pick up the Infusor tubing, remove the Luer Cap and connect it to the catheter. 7 le if not re possib e NB - Wh Infusor r of the restricto to the e taped should b cilitate fa skin to patients Store the Luer Cap in the bag the Infusor came in. Unclamp the catheter so that the infusion can commence. The patient should place the Infusor or Intermate in the mesh bag or belt bag provided, where the damaged. Disconnecting the Infusor or Intermate 1 When the Infusor or Intermate is empty remove it from the catheter. If please refer to the section 2 Close the clamp on the catheter and disconnect the Luer Connector end of the Infusor or Intermate from your catheter by gently twisting anti-clockwise. 3 Flush the catheter the way you have been instructed and attach a new sterile end cap. Place the Luer Cap you saved earlier on the end of the Infusor or Intermate. Dispose of the empty Infusor or Intermate the way you have been directed. 5 What to do if the medication does not infuse 1. Remember the Infusor or Intermate sure you have waited long enough. make 2. Check that the IV line is unclamped and that there are no kinks in the line. 3. clamp the catheter and disconnect the Infusor or Intermate. Replace the Luer Cap on the end of the Infusor or Intermate tubing. 4. Make a note of the Infusor or Intermate code number. 1. Immediately clamp the catheter. What to do if the Infusor or Intermate leaks or bursts 2. Disconnect the Infusor or Intermate and replace the Luer Cap on the end of the Infusor or Intermate tubing. 3. Attach a new Infusor or Intermate, or cap the catheter. 4. 5. If your hospital or community service has provided you with 6. Make a note of the Infusor or Intermate code number. Do not use the device if The expiration date on the label has passed. The name on the label is incorrect. The balloon has burst or is split. There is any sign of leaking drug. There is a split or break in the tubing. The Luer Cap has been removed or is missing. The Fill Port Protector Cap is missing or has fallen off. 6 Checking the progress of the infusion The patient patient may may receive receive more more than than one one Infusor Infusor or or Intermate Intermate to to deliver deliver all all their The their medication. Depending onnot theto type of Infusor or Intermate was medication. It is very important change to a new Infusor orthat Intermate given, it will take isapproximately 30 minutes to 7 days forthe or or until the old one completely empty. Depending on the typeInfusor of Infusor Intermate that to empty. Intermate was given, it will take approximately 30 minutes to 7 days for the Infusor or Intermate to empty. Small-Volume Infusor, Large-Volume Infusor, Small-Volume Intermate, Large-Volume Intermate You will know when the Intermate or Large-Volume Infusor is empty as the balloon will be touching all eight empty indicator bumps on two sides ofthe Infusor or Intermate. The Infusor or Intermate works slowly so the balloon will appear to be shrinking over several hours or days. 7KHGLDJUDPEHORZVKRZV\RXDSSUR[LPDWHO\KRZWKHEDOORRQGHÁDWHVRYHUWLPH Full 1/4 Delivered 1/2 Delivered 3/4 Delivered Empty Volume Indicator Buttons The Infusor Volume Indicator when Infusor is full 7KHEDOORRQZLOOEHGHÁDWHGZKHQHPSW\ 7 Protection Cap Balloon Indicator Bumps Luer Connector Winged Luer Cap Large Volume Infusor ™ Small Volume Infusor ™ Protection Cap Balloon Winged Luer Cap Luer Connector 4 Parameters for Use Temperature Viscosity The Infusor device is designed to operate at the The Infusor device is designed to operate at the nominal 2C1073KJ, 2C1063K, and 2C1009K are at a temperature of 31.1° C (88°F). All other Infusor codes There will be an approximate 10% increase in the used. The Intermate device is designed to operate at the The Intermate device is designed to operate at the Flow rate will decrease approximately 2.3% per 1° C (1.8° F) decrease in temperature and will increase approximately 2.3% per 1° C (1.8° F) increase in temperature. Head height Flow rate of the Infusor device is optimised when the Elastomeric Reservoir and the Distal End Luer Lock are positioned at the same height. Flow rate will decrease approximately 0.5% per 2.54 cm (1 inch) if the Elastomeric Reservoir is positioned below the Distal End Luer Lock. Flow rate will increase approximately 0.5% per 2.54 cm if the Elastomeric Reservoir is positioned above the Distal End Luer Lock. 10 when 5% Dextrose (D5W) is used. Catheter size When delivering solution through a catheter refer to the directions for use provided by the catheter manufacturer. The length, diameter, and location of the catheter can diameter catheter should be used with the Infusor to An 18 gauge (4 French) or larger diameter catheter should be used with the Intermate to achieve nominal 5 Troubleshooting Problem Description High Flow Where was the flow restrictor placed on the patient? The Infusor operates at the labelled nominal rate when the Infusor skin in the correct location (See temperature information.) Infusor Intermate operates at the labelled nominal rate Intermate contents must be at room temperature in order for the Intermate information.) What was the viscosity of the solution in the device? See viscosity information. Was the flow within tolerance? The Infusor Intermate Was any direct heat source (heating pads, heated water bed, heating blanket) or indirect heat source (sunlight) placed on or near the flow restrictor of the Infusor or the housing of the Intermate? Was the patient’s body temperature elevated? Direct or indirect heating of the Infusor Intermate What volume of drug/diluent was used in the device? Infusor Was the flow restrictor placed at the same head height as the Infusor? See the Head Height information. 11 Problem Description Low Flow & No Flow Was the flow within tolerance? The Infusor Intermate Was the flow restrictor in contact with any cooling source? Was the flow restrictor taped to the patient’s skin? Was the filled Intermate brought to room temperature prior to use? restrictor will change the viscosity of the drug solution contained inside – thereby changing the Cooling the Infusor or Intermate Infusor The Intermate What was the viscosity of the solution in the device? See Viscosity information. What volume of drug/diluent was used in the device? Infusor chart. Was the flow restrictor placed at the same head height as the Infusor? See Head Height information. Was air removed from the Infusor tube set and flow restrictor prior to use? Was flow verified by visualising 2-3 drops of fluid flowing from the flow restrictor at the time of the filling and at the time of use? Air in the Infusor 12 Problem Description Priming Difficulty Were Baxter filling chart instructions followed? Was the Infusor filled slowly? Was the Infusor filled while holding the device in a vertical position? our Quality Assurance Laboratories. This technique should be used for optimal priming Infusor very slowly. Remember to gently and slowly crack Was force-priming technique utilised? Was continuous suction applied during force-priming? Was three-way stopcock open during force priming? Was a 10mL or smaller syringe used to force prime the device? results. Problem description Leaks Was the fill port capped after filling? Was the fill port swabbed after filling? this type of complaint report, suggest that the customer wipe away residual solution with leakage of this residual solution. Was the Winged Luer Cap tightened after filling the device? The Winged Luer Cap is not tightened during the manufacturing process. The Customer Problem description Ruptures Was the Infusor stored in the presence of sunlight or UV light? Sunlight or UV light may damage the Elastomeric material of the Infusor and Intermate reservoirs. 13 6 Large Volume Infusor Specifications Name LV10 LV5 LV2 LV1.5 Code 2C1063KP 2C1009KP 2C1008KP 2C1087KP 1 day 2 days 5 days 7 days 240 mL 240 mL 240 mL 252 mL 31.1° 31.1° 33.3° 33.3° 21.8-26.7 hrs 43.6-53.3 hrs 109.1-133.3 hrs 152.7-186.7 hrs Nominal Infusion duration Nominal Flow Rate Nominal Fill Volume Nominal Temperature Flow Rate Accuracy Acceptable Flow Times Folfusor Specifications Name SV2.5 SV0.5 SV5 Code 2C4711K 2C4700K 2C4705K 2 days 7 days 1 Day 120 mL 84 mL 120 mL 33.3° 33.3° 33.3° 43.4-53.2 hrs 153.4-186.2 hrs 21.49-26.40 hrs Nominal Infusion duration Nominal Flow Rate Nominal Fill Volume Nominal Temperature Flow Rate Accuracy Acceptable Flow Times Small Volume Infusor Specifications Name Half Day Single Day Two Day Multi Day Seven Day Code 2C1073KJP 2C1071KJP 2C1075KJP 2C1080KJP 2C1082KJ 12 hours 1 days 2 days 5 days 7 days Nominal Fill Volume 60 mL 48 mL 96 mL 60 mL 84 mL Nominal Temperature 31.1° 33.3° 33.3° 33.3° 33.3° 10.7-13.7 hrs 21.3-27.4 hrs 42.7-54.9 hrs 106.7-137.1 hrs 149.3-192.0 hrs Nominal Infusion duration Nominal Flow Rate Flow Rate Accuracy Acceptable Flow Times 14 Acceptable Flow Times at Nominal Conditions Intermate Specifications Name SV200 SV100 SV50 LV250 LV100 LV50 XLV250 Code 2C1714K 2C1712K 2C1710K 2C1724K 2C1722K 2C1720K 2C1754K 30 mins 60 mins 120 mins 60 mins 2.5 hrs 5 hrs 120 mins 100 mL 100 mL 100 mL 250 mL 250 mL 250 mL 500mL 21.1° 21.1° 21.1° 21.1° 21.1° 21.1° 21.1° 26-35 mins 52-71 mins 104-141 mins 52-71 mins 2.2-2.9 hrs 4.3-5.9 hrs 1.4-2.2 hrs Nominal Infusion duration Nominal Flow Rate Nominal Fill Volume Nominal Temperature Flow Rate Accuracy Acceptable Flow Times Accessories Specifications Name Belt Bag 18 inch waist strap Belt Bag Small Mesh Bag for the Infusor Code IPB102XLX1 2C1100 BG3386WH 30 6 500 Pack Size Infusor Applications LV the Infusor Large volume the Infusor used for Chemotherapy, Antibiotics and Pain Management SV the Infusor Small Volume the Infusor used for Chemotherpay and Pain Management Folfusors Small Volume the Infusor for Chemotherapy The Intermate Fast flowing devices for Antibiotics and IVig Infusions 15 7 Can concurrent Infusions be run with the Baxter Infusor? Why is it important to place the end of the administration tubing close to the skin? Yes. Concurrent infusions may be run via a Y-Site or The end of the administration tubing is where the Infusor rate of the Infusor may decrease, particularly if the pressure of the alternate infusion device is high. It is also Infusor restrictor is calibrated to work best at a temperature of 31-33°C so placement next to the skin helps to maintain this constant temperature. from one line into the other. Is the Infusor Recyclable? The Infusor is made from recyclable material, however disposal of the device should be in accordance with individual hospital protocol. Can the Infusor be used by patients with latex allergies? Yes, all Baxter Infusor, Folfusor and Intermate devices are free of natural latex. 16 Can the Infusor be used inside MRI machines or Hyperbaric chambers? Yes, the Infusor does not contain any metal so is suitable to go through an MRI machine. The Infusor may also be used inside hyperbaric chambers. As long as the patient is exposed to the same changes in pressure as the Infusor device there is no hindrance to the infusion. Frequently Asked Questions Quick Reference Guide Can extension sets be used with the Baxter Infusor? A small air bubble is noticeable in the filled Infusor reservoir – is this an issue? at the distal end of the Infusor administration tubing should still be taped to the skin if possible. Extension sets should be primed prior to connection to the patient. As a general guide, overall infusion time will be marginally lengthened when using an extension set. of air bubbles are introduced into the reservoir. These port of the devices. The total volume of these bubbles Can Baxter Infusor and Intermate devices be used during flight? Yes, Baxter has conducted internal testing to establish the effects of cabin pressure on indicate that the reduced pressure environments such as effect on solution de-gassing. Neither reduced pressure environment nor changes in gravitational acceleration technique is used. Air that is inadvertently introduced during the compounding process cannot be withdrawn through the system (ie. syringe, diluent container, or transfer set) prior 17 18 19 For further information and support for your Baxter Customer Support on: Australia: 1300 789 646 New Zealand: 0800 229 837 AUSTRALIA Baxter Healthcare Pty Ltd ABN 43 000 392 781 1 Baxter Drive, Old Toongabbie NSW 2146 Australia Tel: +612 9848 1111 www.baxterhealthcare.com.au NEW ZEALAND Baxter Healthcare Ltd 33 Vestey Drive, Mount Wellington Auckland 1060, New Zealand Tel: +649 574 2400 www.baxter.co.nz www.thehomecalling.com.au www.baxterhealthcare.com.au Alternatively, please visit our website © 2012 Baxter Healthcare Pty Ltd. Infusor, Folfusor and Intermate are trademarks of Baxter International Inc. www.thehomecalling.com AUS2012PRO0036 for additional technical and clinical information. 1